Welcome to our dedicated page for Palvella Therapeutics news (Ticker: PVLA), a resource for investors and traders seeking the latest updates and insights on Palvella Therapeutics stock.
Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company developing investigational topical therapies for serious, rare skin diseases and vascular malformations that currently have no FDA-approved treatments. News about Palvella often centers on progress across its QTORIN™ platform, including clinical trial milestones, regulatory designations, and pipeline expansion.
The company’s lead candidate, QTORIN™ 3.9% rapamycin anhydrous gel, is being studied in the Phase 3 SELVA trial for microcystic lymphatic malformations and in the Phase 2 TOIVA trial for cutaneous venous malformations, with additional development planned in clinically significant angiokeratomas. Updates on these programs include topline clinical results, details on trial design, and commentary from investigators and company leadership on efficacy and safety findings.
Palvella also reports news on its second product candidate, QTORIN™ pitavastatin, for disseminated superficial actinic porokeratosis, including announcements of its selection as a new QTORIN-derived therapy and plans for Phase 2 clinical evaluation. Regulatory and grant-related news, such as FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations and Orphan Products Grant funding, provide additional context on how regulators view the unmet need in the company’s target indications.
Investors and observers following PVLA news can expect coverage of quarterly financial results, corporate updates, leadership appointments in areas like medical affairs and innovation, and participation in healthcare conferences. This news stream helps track how Palvella advances its investigational programs, manages its development priorities, and positions its QTORIN™ platform within the rare dermatologic disease landscape, while consistently noting that its product candidates remain investigational and unapproved.
Palvella Therapeutics (Nasdaq: PVLA) announced publication of a systematic review in Clinical and Experimental Dermatology synthesizing real-world evidence for topical statins in porokeratosis.
The review covers 24 studies (95 patients), reports mostly partial clinical benefit, underscores genetic mevalonate-pathway rationale, and notes no FDA-approved therapies. Palvella expects QTORIN™ pitavastatin to enter Phase 2 in H2 2026.
Palvella Therapeutics (NASDAQ: PVLA) provided a 2026 corporate update outlining progress across its late-stage QTORIN platform for rare skin diseases and vascular malformations. The Phase 3 SELVA trial of QTORIN rapamycin for microcystic lymphatic malformations enrolled 51 patients (vs 40 target) and expects topline results in March 2026; an NDA submission is planned in H2 2026 if results are positive. A positive Phase 2 in cutaneous venous malformations (TOIVA) reported 73% improvement and a Preliminary Breakthrough Advice meeting with FDA is requested for Q1 2026. Additional Phase 2 starts and a new QTORIN candidate are planned in H2 2026. IP extends through 2038 for rapamycin and potential 2046 for pitavastatin. Leadership hires strengthen commercial and technical teams.
Palvella Therapeutics (Nasdaq: PVLA) announced the appointment of Vimal Patel, PharmD as Senior Vice President of Medical Affairs effective Jan. 7, 2026. Patel brings more than 25 years of dermatology and immunology medical affairs leadership across late‑stage development, launches, and lifecycle management.
He will lead medical strategy, KOL engagement, disease state awareness, and medical education for Palvella’s QTORIN™ programs targeting serious, rare skin diseases including microcystic lymphatic malformations and cutaneous venous malformations.
Palvella Therapeutics (Nasdaq: PVLA) announced the FDA Fast Track Designation for QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of angiokeratomas.
The designation is intended to facilitate development and expedite review; QTORIN™ rapamycin may be eligible for Accelerated Approval and Priority Review if criteria are met. Palvella plans a Phase 2 study of ~10–20 patients, with an FDA meeting in H1 2026 and study initiation expected in H2 2026. Angiokeratomas affect an estimated more than 50,000 diagnosed U.S. patients and currently have no FDA‑approved therapies.
Palvella Therapeutics (NASDAQ: PVLA) reported positive topline Phase 2 TOIVA results for QTORIN™ 3.9% rapamycin gel in cutaneous venous malformations on Dec 15, 2025. Key findings at Week 12: 73% (11/15) improved on the Overall cVM-IGA and 67% (10/15) were rated “Much” or “Very Much Improved.” Multiple clinician- and patient-reported endpoints reached nominal statistical significance. QTORIN was generally well tolerated with no drug-related serious adverse events and systemic rapamycin levels below assay quantification. Palvella plans near-term FDA discussions on Breakthrough Therapy and a Phase 3 pivotal study; FDA previously granted Fast Track designation.
Palvella Therapeutics (NASDAQ: PVLA) reported third quarter 2025 results and a corporate update on Nov 11, 2025. The company has an expanded QTORIN™ pipeline with four rare skin disease programs and expects topline Phase 2 TOIVA results for QTORIN™ rapamycin in cutaneous venous malformations in mid-December 2025 and Phase 3 SELVA results for microcystic lymphatic malformations in Q1 2026. New programs include angiokeratomas and QTORIN™ pitavastatin for DSAP, with Phase 2 starts anticipated in the second half of 2026. Cash and cash equivalents were $63.6M as of Sept 30, 2025, expected to fund operations into the second half of 2027.
Palvella Therapeutics (Nasdaq: PVLA) announced that Founder and CEO Wes Kaupinen will present at the Stifel 2025 Healthcare Conference on Wednesday, November 12, 2025 at 4:00 p.m. ET.
A live webcast will be available on the company's Events and Presentations page at www.palvellatx.com, and an archived replay will be accessible for approximately 90 days after the presentation.
Palvella Therapeutics (NASDAQ: PVLA) announced a new topical product candidate, QTORIN™ pitavastatin, for disseminated superficial actinic porokeratosis (DSAP), a rare premalignant genetic skin disease with no FDA‑approved therapies and an estimated >50,000 diagnosed U.S. patients.
The company plans an FDA meeting in the first half of 2026 to discuss a proposed Phase 2 design and anticipates initiating the Phase 2 trial in the second half of 2026. Palvella cited genetic evidence and published case studies supporting topical statins and highlighted pitavastatin's potency as rationale for development. A webcast conference call was held on November 5, 2025 to discuss the candidate.
Palvella Therapeutics (Nasdaq: PVLA) will report third quarter 2025 financial results before market open on Tuesday, November 11, 2025. Management will host a conference call for investors at 8:30 a.m. ET the same day to discuss results and provide a corporate update.
A live webcast with slides will be available via the company's Events & Presentations page and a phone registration link will supply dial-in details. A replay of the webcast will be posted approximately 2 hours after the call and will be archived for 90 days at www.palvellatx.com.
Palvella Therapeutics (NASDAQ:PVLA) received Year Two funding from the FDA Office of Orphan Products Development for its Phase 3 SELVA trial of QTORIN™ 3.9% rapamycin for microcystic lymphatic malformations.
The grant provides up to $2.6 million in non-dilutive funding over four years. SELVA is a 24-week, single-arm, baseline-controlled trial that enrolled 51 subjects (target 40) and remains on track for top-line results in Q1 2026. Palvella plans an NDA submission in the second half of 2026 assuming positive results. QTORIN has Breakthrough Therapy, Orphan Drug, and Fast Track designations and could qualify for 7 years of U.S. orphan exclusivity if approved.
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